Introduction:

Focal therapy represents a minimally invasive treatment approach for prostate cancer, aiming to minimize side effects while effectively managing the disease. This approach employs various energy sources such as high-intensity focused ultrasound (HIFU), cryoablation, laser ablation, and irreversible electroporation (IRE). The Manufacturer and User Facility Device Experience (MAUDE) database, maintained by the Food and Drug Administration (FDA), is a publicly available repository that collects reports of adverse events involving medical devices. By utilizing the MAUDE database, this study assesses the real-world safety profile of medical devices used in focal prostate cancer treatment

Methods:

The MAUDE database was searched for reports on HIFU, cryoablation, laser ablation, and IRE devices used in prostate cancer treatment from 1993 to 2023. Adverse events were identified and categorized based on their nature and severity.

Results:

We identified 175 reports for HIFU, 1362 for cryoablation, 615 for laser ablation, and 135 for IRE devices, with 28, 284, 126, and 2 respective reports directly related to prostate cancer treatment. The aggregated data revealed that the majority of complications were minor, with 82.5% (n=363 out of 440 total complications) classified as Clavien-Dindo grade 1 or 2. Common minor complications included erectile dysfunction and urinary retention. Severe complications such as rectal fistulas were noted in HIFU and IRE treatments, along with a singular mortality due to pulmonary embolism in cryoablation.

Conclusion:

Our analyses from MAUDE reveal that devices used in focal therapy for prostate cancer are predominantly associated with minor complications, underscoring their overall real-world safety profile. However, the occurrence of severe adverse events emphasizes the critical importance of rigorous patient selection and meticulous procedural planning. These findings provide valuable insights into the safety profile of focal therapy devices and contribute to the growing body of evidence on their use in prostate cancer treatment.

Funding: n/a